Senior Clinical Research Associate

Parexel

Senior Clinical Research Associate managing monitoring and site activities for client Sponsored studies. Ensuring compliance and effective communication with cross-functional teams in clinical development.

Posted 6/24/2026full-timeRemote • Texas • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
Partner with Clinical Trial Liaison (CTL) and other client functions to support site activation and deliverables.
Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements.
Prepare and maintain Oversight Monitoring Plan.
Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA.
Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.

Requirements

What you’ll need

Bachelor's degree (or equivalent)
Minimum of 5 years of monitoring experience
Experience with Phase I Oncology studies
Ability to travel to other regions for SWAT and/or oversight visits
Strong analytical problem-solving skills and critical thinking abilities.
Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).

Benefits

Comp & perks

Health insurance
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

monitoring experiencedrug accountabilityprotocol complianceOversight Monitoring Plansafety reportingprotocol deviationsclinical drug development processPhase I Oncology studiesICH GCPregulatory requirements

Soft Skills

analytical problem-solvingcritical thinkingeffective communicationrelationship buildingproblem-solving

Certifications

Bachelor's degree